This protocol describes an individually randomized trial that will include adult people living with HIV (PLHIV) currently receiving HIV care at one of two participating health facilities and identified as high risk for disengagement from care by a machine learning algorithm. Participants randomized to the control arm will receive standard of care HIV clinical services according to Tanzania's National Guidelines for the management of HIV. For those who meet clinic eligibility criteria for enhanced adherence counseling, which at the included study sites is when client's viral load reaches a detectable level (\>1000 copies/ml), this includes the standard provision of three, once-monthly, 60-minute nurse-led individual, enhanced adherence counseling sessions, starting on the day of the result and for two months after. Intervention arm participants will receive the same standard HIV care services plus the offer of a cash transfer paired with visit attendance and attendance at each of the three adapted enhanced adherence counseling sessions (referred to as PKC sessions).
This protocol describes a 2-armed parallel individually randomized controlled trial for which 692 PLHIV who meet eligibility criteria, are currently accessing care at a participating health facility (Katoro Health Center, Geita Town Council Hospital, Geita Regional Referral Hospital, or Nyankumbu Health Center), and have provided informed consent to be part of the study will be randomized in a 1:1 ratio (n=346 PLHIV in each arm), stratified by site, to the control or intervention group. The investigators will use machine learning to finalize a predictive model based on routinely collected medical and pharmacy record data to identify and recruit PLHIV for participation at participating facilities who are at high-risk for disengaging from HIV care. Eligible and consenting participants randomized to the control arm will receive standard of care HIV clinical services according to Tanzania's National Guidelines for the Management of HIV. Criteria for enrollment into enhanced adherence counseling sessions includes when client's viral load reaches a detectable level (\>1000 copies/ml). Enhanced adherence counseling includes the standard provision of three, once-monthly, 60-minute nurse-led individual, enhanced adherence counseling sessions, starting on the day of the result and for two months after. Counseling focuses on the meaning of viral loads and supportive, non-judgmental strategies for adherence and visit attendance. Sessions are conducted in an individual, 1:1 setting with a trained counselor who is on the clinical staff, or in a group setting with a trained counselor who is on the clinical staff. A minimum of three sessions are required. Eligible and consenting participants randomized to the intervention arm will receive the same standard HIV care services plus the offer of a cash transfer paired with visit attendance and attendance at each of the three adapted enhanced adherence counseling sessions (PKC sessions). The first payment will occur at enrollment; the next two cash transfers are payable upon visit attendance and attendance of the two remaining enhanced adherence counseling sessions. Due to the nature of the intervention, participants will not be blinded to intervention assignment. The primary endpoint is viral load suppression (\<1000 copies/ml) at 12 months following study enrollment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
692
The intervention includes up to 3 cash transfers of 22,500 Tanzanian Shillings (\~$10) paired with attendance at each of the three adapted enhanced adherence counseling sessions (PKC sessions). The first cash transfer will occur at enrollment; the next two cash transfers are payable upon visit attendance and attendance of the two remaining PKC sessions. The cash transfers will include extra funds for transaction fees, typically \<$1.
Geita Regional Referral Hospital
Geita, Tanzania
Geita Town Council Hospital
Geita, Tanzania
Nyankumbu Health Center
Geita, Tanzania
Katoro Health Center
Katoro, Tanzania
12-Month Viral Suppression
The proportion of people living with HIV (PLHIV) and on ART with suppressed HIV viral load ( \<1000 copies/ml) at 12 months after study enrollment.
Time frame: 12 months
6-month retention in care
The proportion of people living with HIV (PLHIV) on ART at 6 months after study enrollment (PEPFAR considers those not retained on ART to include those who died, disengaged from care, stopped ART, or had no evidence of care for ≥28 days after a missed visit. Participants not found after exhaustive tracing efforts to rule out silent transfers will be classified as not retained on ART)
Time frame: 6 months
12-month retention in care
The proportion of people living with HIV (PLHIV) on ART at 12 months after study enrollment (PEPFAR considers those not retained on ART to include those who died, disengaged from care, stopped ART, or had no evidence of care for ≥28 days after a missed visit. Participants not found after exhaustive tracing efforts to rule out silent transfers will be classified as not retained on ART)
Time frame: 12 months
12-month durable viral load
Proportion with durable HIV viral suppression 12 months after enrollment: at least 2 viral load measurements taken from up to 6 months prior to study enrollment and up to and including 12 months following study enrollment and all are undetectable (\<1000 copies/ml) will have met criteria for durable viral suppression at 12 months.
Time frame: 12 months
12-month Appointment Attendance
The proportion of scheduled visits that were completed during the 0-12 month period
Time frame: 12 months
6-month Appointment Attendance
The proportion of scheduled visits that were completed during the 0-6 month period
Time frame: 6 months
12-month Mortality
The cumulative incidence of mortality at 12 months after study enrollment
Time frame: 12 months
6-month Predictive value positive (PVP) of machine learning algorithm
Predictive value positive (PVP) of the machine learning algorithm in identifying PLHIV at-risk of disengagement from HIV care within 6 months
Time frame: 6 months
12-month Predictive value positive (PVP) of machine learning algorithm
Predictive value positive (PVP) of the machine learning algorithm in identifying PLHIV at-risk of disengagement from HIV care within 12 months
Time frame: 12 months
6-month PVP of routine clinical criteria
PVP of the routine clinical criteria (i.e. recent missed visit or detectable viral load, \>1000 copies/ml) for identifying PLHIV at-risk of disengagement from HIV care within 6 months
Time frame: 6 months
12-month PVP of routine clinical criteria
PVP of the routine clinical criteria (i.e. recent missed visit or detectable viral load, \>1000 copies/ml) for identifying PLHIV at-risk of disengagement from HIV care within 12 months
Time frame: 12 months
6-month Predictive value negative (PVN) of the machine learning algorithm
Predictive value negative (PVN) of the machine learning algorithm in identifying PLHIV not at-risk of disengagement from HIV care within 6 months
Time frame: 6 months
12-month PVN of the machine learning algorithm
PVN of the machine learning algorithm in identifying PLHIV not at-risk of disengagement from HIV care within 12 months
Time frame: 12 months
6-month PVN of routine clinical criteria
PVN of the routine clinical criteria for identifying PLHIV not at-risk of disengagement from HIV care within 6 months
Time frame: 6 months
12-month PVN of routine clinical criteria
PVN of the routine clinical criteria for identifying PLHIV not at-risk of disengagement from HIV care within 12 months
Time frame: 12 months
Enhanced Adherence Counseling Session Attendance
Proportion of enhanced adherence counseling sessions completed among sessions scheduled
Time frame: 6 months
Viral Suppression with enhanced adherence counseling completion
Proportion with HIV viral suppression after completion of enhanced adherence counseling sessions
Time frame: 6 months
6-Month Viral Suppression (<1000 copies/ml)
The proportion of people living with HIV (PLHIV) and on ART with suppressed HIV viral load ( \<1000 copies/ml) at 6 months after study enrollment.
Time frame: 6 months
6-Month Viral Suppression (<50 copies/ml)
The proportion of people living with HIV (PLHIV) and on ART with suppressed HIV viral load ( \<50 copies/ml) at 6 months after study enrollment.
Time frame: 6 months
12-Month Viral Suppression (<50 copies/ml)
The proportion of people living with HIV (PLHIV) and on ART with suppressed HIV viral load ( \<50 copies/ml) at 12 months after study enrollment.
Time frame: 12 months
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